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    Association details:
    Biomarker:No biomarker
    Cancer:Chronic Lymphocytic Leukemia
    Drug:Copiktra (duvelisib) (PI3Kδ inhibitor, PI3Kγ inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    PRNewswire
    Title:

    COPIKTRA® (duvelisib) Receives European Union Marketing Authorization for the Treatment of Relapsed or Refractory CLL and Refractory FL

    Published date:
    06/09/2021
    Excerpt:
    Secura Bio, Inc...today announced that...the European Medicines Agency granted marketing authorization for COPIKTRA as monotherapy for the treatment of relapsed or refractory Chronic Lymphocytic Leukemia (CLL) in patients, who have received at least two prior therapies and for the treatment of Follicular Lymphoma (FL) that is refractory to at least two prior systemic therapies.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:...Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Chronic lymphocytic leukemia/Small lymphocytic lymphoma...CLL/SLL without del(17p)/TP53 mutation…Second-line and subsequent therapy…Preferred regimens…Duvelisib